Pharmaceutical facility design guidelines


1. Introduction

1.1 Objective

1.2 Scope and applicability

1.3 Facility goal

2. Concepts and regulatory philosophy

2.1 Product and process requirements

2.2 Critical process steps

2.3 Protection of the product

2.4 Cross contamination and potent product issues

2.5 Aseptic processing area

2.6 Integrated facility design

2.7 Terminology for manufacturing areas and HVAC

2.8 Barrier-isolator technology

2.9 Other considerations

2.10 Good engineering practice, direct impact systems and indirect impact systems

3. Product and equipment considerations

3.1 Introduction

3.2 Process description

3.3 Alternative technologies

3.4 Equipment integration

3.5 Equipment – technical considerations

3.6 Considerations for equipment selection

4. Architecture and layout

4.1 Introduction

4.2 Design criteria

4.3 Layout considerations

4.4 Room function

4.5 Surface finishes & materials of construction

4.6 Transfer zones

5. HVAC

5.1 Introduction

5.2 Sources of particulate contamination

5.3 Environmental standards and GMP

5.4 Room relative pressure

5.5 HVAC system design

5.6 System filtration levels

5.7 Monitoring

6. Utility systems

6.1 Introduction

6.2 Descriptions and general considerations

6.3 Specific service considerations

7. Electrical

7.1 Introduction

7.2 General requirements

7.3 Power distribution

7.4 Lighting

7.5 Hazardous environments

7.6 Wiring

7.7 Door interlocks

7.8 Outlets and miscellaneous equipment

8. Control and instrumentation

8.1 Introduction

8.2 GMP critical environmental parameters

8.3 Production process parameters

8.4 Instrumentation

8.5 Electrical installation

8.6 General design issues

8.7 HVAC

9. Cleaning: engineering issues

9.1 Manual cleaning for equipment and facility

9.2 Semi-automatic cleaning

10. Barrier-isolator technology

10.1 Introduction

10.2 Barrier-isolator type

11. General considerations

11.1 Introduction

11.2 Environmental – air

11.3 Environmental – waste water

11.4 Environmental – noise

11.5 Environmental – solid and concentrated wastes

11.6 Health and safety

11.7 Site selection and location

11.8 Energy sources

11.9 Auditing, monitoring and reporting

11.10 Security

12. Commissioning & qualification

12.1 Introduction

12.2 Philosophy

12.3 Commissioning & qualification phases related to the stage gate process

12.4 Commissioning, qualification, & validation specific requirements

13. Appendix 1 – references

13.1 Overview of the standardization process

13.2 Standards

13.3 General references

13.4 Gowning philosophy

13.5 Conceptual diagrams and requirements table

13.6 HVAC diagrams

13.7 Electrical references

13.8 Instrumentation and controls references

14. Appendix 2 – HVAC European considerations

14.1 Introduction

14.2 Key differences to U.S. standards

15. Appendix 3 – HVAC – additional engineering information

15.1 Introduction

15.2 Sources of particulate contamination

15.3 HVAC design principles

15.4 Calculation of air change rate

15.5 Process impact

15.6 HVAC system design

15.7 Air handling unit (AHU) design considerations

15.8 Horizontal vs vertical unidirectional airflow

Duration
3 days
Language
English
Participants
8 - 15
Fees